Surgical end effectors

ABSTRACT

According to an aspect of the present disclosure, an end effector for use with a surgical device is provided. The end effector includes a drive assembly, a driver, a needle assembly and a biasing element. The driver is disposed in mechanical cooperation with the drive assembly. Rotation of the drive assembly in a first direction causes distal translation of the driver with respect to the drive assembly. The needle assembly is disposed in mechanical cooperation with the driver. Distal translation of the driver causes a corresponding distal translation of the needle assembly. The biasing element is disposed in mechanical cooperation with the needle assembly and is configured to bias the needle assembly proximally.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a divisional of U.S. patent application Ser. No.15/678,149, filed on Aug. 16, 2017, which claims the benefit of andpriority to U.S. Provisional Patent Application No. 62/410,876, filedOct. 21, 2016, the entire disclosures of each of which are incorporatedby reference herein.

BACKGROUND Technical Field

The present disclosure relates to end effectors for use with a surgicaldevice for performing endoscopic surgical procedures and methods of usethereof. More specifically, the present disclosure relates to endeffectors for advancing at least a portion of a needle into tissue.

Background of Related Art

During laparoscopic or endoscopic surgical procedures, access to asurgical site is achieved through a small incision or through a narrowcannula inserted through a small entrance wound in a patient. Severaltypes of such surgical procedures include advancing at least part of aneedle and/or suture into tissue. For example, it may be desired toinsert a suture (e.g., a barbed suture) through an implant (e.g., mesh)and into tissue to help secure the implant to tissue. It may also bedesired to replace suture that was previously inserted through theimplant.

Additionally, after a needle is advanced into tissue, it may be desiredto retract the needle in an outer tube of a surgical device or an endeffector to prevent or minimize unintended contact between the needleand a physician, for instance.

Accordingly, a need exists for endoscopic surgical devices or endeffectors for use therewith including the ability to advance and retracta needle into its outer tube.

SUMMARY

The present disclosure relates to an end effector for used with asurgical device. The end effector includes a drive assembly, a driver, aneedle assembly, and a biasing element. The driver is disposed inmechanical cooperation with the drive assembly. Rotation of the driveassembly in a first direction causes distal translation of the driverwith respect to the drive assembly. The needle assembly is disposed inmechanical cooperation with the driver. Distal translation of the drivercauses a corresponding distal translation of the needle assembly. Thebiasing element is disposed in mechanical cooperation with the needleassembly. The biasing element is configured to bias the needle assemblyproximally.

In disclosed embodiments, the biasing element includes a compressionspring. It is further disclosed that the biasing element is disposeddistally of a proximal base of the needle assembly.

In aspects of the present disclosure, the end effector also includes anend cap disposed adjacent a distal portion of the driver. The end cap isdistally translatable with respect to the drive assembly.

It is also disclosed that the end effector includes a lock disposed inmechanical cooperation with a portion of the end cap. The lock may beconfigured to help prevent the needle assembly from moving proximallywith respect to the driver until the needle assembly has reached apredetermined longitudinal position. In embodiments, the lock ispivotable with respect to the end cap. It is further disclosed that thelock is movable from a first position where a portion of the lockengages a portion of the needle assembly to a second position where thelock is free from engagement with the needle assembly. Additionally, itis disclosed that when the lock is in the first position, the lockresists a bias against the needle assembly provided by the biasingelement, and when the lock is in the second position, the needleassembly is movable in a proximal direction with respect to the driver.

In a disclosed embodiment, the end effector includes an outer tubedisposed radially outward of the driver. Engagement between a portion ofthe lock and an inner wall of the outer tube prevents the lock frommoving toward the second position.

It is further disclosed that the driver includes a distal slotconfigured to allow a portion of the lock to pass therethrough.

It is also disclosed that the drive assembly includes a helical grooveconfigured to engage a portion of the driver. Additionally, the driveassembly is fixed from longitudinal movement with respect to the outertube.

In disclosed embodiments, the needle assembly includes a first needleextending distally from a needle block, and second needle extendingdistally from the needle block. The first needle is parallel to thesecond needle.

It is further disclosed that the end effector includes a suture disposedin mechanical cooperation with a needle of the needle assembly.

The present disclosure also relates to an end effector for use with asurgical device, where the end effector includes a drive assembly, aneedle assembly, a helix assembly, and biasing element. The needleassembly is disposed in mechanical cooperation with the drive assembly.Rotation of the drive assembly in a first direction causes acorresponding rotation of the needle assembly. The needle assemblyincludes a pin. The helix assembly is disposed in mechanical cooperationwith the needle assembly, and includes a proximal end and a longitudinalslot. The biasing element is disposed in mechanical cooperation with theneedle assembly and is configured to bias the needle assembly distallywith respect to the drive assembly. The needle assembly is movable withrespect to the helix assembly from a first position where the pin is outof alignment with the longitudinal slot of the helix assembly, to asecond position where the pin is aligned with the longitudinal slot ofthe helix assembly, to a third position where the pin has been distallytranslated with respect to the helix assembly.

In disclosed embodiments, a predetermined amount of rotation of thedrive assembly with respect to the helix assembly causes a correspondingrotation of the needle assembly with respect to the helix assembly suchthat the needle assembly moves from its first position to its secondposition.

It is further disclosed that when the needle assembly is in the firstposition, engagement between the pin of the needle assembly and theproximal end of the helix assembly prevents the needle assembly frommoving distally with respect to the drive assembly. Additionally, whenthe needle assembly is in the second position, the biasing elementcauses the pin to move distally within the longitudinal slot of thehelix assembly such that the needle assembly is moved to the thirdposition.

It is also disclosed that rotation of the drive assembly when the needleassembly is in the third position causes the helix assembly to rotatewith respect to an outer tube. It is further disclosed that rotation ofthe helix assembly with respect to the outer tube causes proximalmovement of the needle assembly with respect to the outer tube.

In disclosed embodiments, the drive assembly includes a first arm and asecond arm. Each of the first arm and the second arm is configured todirectly contact the needle assembly.

It is further disclosed that the end effector includes a suture disposedin mechanical cooperation with a needle of the needle assembly.

Further details and aspects of exemplary embodiments of the presentdisclosure are described in more detail below with reference to theappended figures.

BRIEF DESCRIPTION OF THE DRAWINGS

Embodiments of the present disclosure are described herein withreference to the accompanying drawings, wherein:

FIGS. 1 and 2 are perspective views of a surgical device including anend effector engaged therewith according to embodiments of the presentdisclosure;

FIG. 3 is an enlarged view of the indicated area of detail of FIG. 2;

FIG. 4 is a perspective view of a distal portion of an elongated portionof the surgical device of FIGS. 1-3;

FIGS. 5-8 illustrate various types of needles and sutures in accordancewith embodiments of the present disclosure;

FIGS. 9-20 illustrate various embodiments showing a needle engaged witha suture in accordance with embodiments of the present disclosure;

FIG. 21 is a perspective view of portions of an end effector inaccordance with embodiments of the present disclosure;

FIG. 22 is an assembly view of the end effector of FIG. 21;

FIG. 23 is a cross-sectional view of a portion of the end effector ofFIGS. 21 and 22;

FIG. 24 is a perspective view of a portion of the end effector of FIGS.21-23;

FIG. 25 is a perspective view of portions of the end effector of FIGS.21-24;

FIG. 26 is an enlarged view of the area of detail indicated in FIG. 25;

FIG. 27 is an enlarged view of the area of detail indicated in FIG. 25;

FIG. 28 is a perspective view of portions of the end effector of FIGS.21-27;

FIG. 29 is a perspective view of the needle of FIG. 28;

FIG. 30 is a perspective view of portions of the end effector of FIGS.21-27 and with a needle in an advanced position;

FIG. 31 is a perspective view of portions of the end effector of FIGS.21-30;

FIG. 32 is an enlarged view of the area of detail indicated in FIG. 31;

FIG. 33 is an enlarged view of the area of detail indicated in FIG. 31;

FIG. 34 is a perspective view of an end effector in accordance withembodiments of the present disclosure;

FIGS. 35 and 36 are cut-away views of portions of the end effector ofFIG. 34;

FIG. 37 is an assembly view of the end effector of FIGS. 34-36;

FIG. 38 is a cross-sectional view of an end effector in accordance withembodiments of the present disclosure;

FIG. 39 is an assembly view of the end effector of FIG. 38;

FIG. 40 is a cut-away view of a portion of the end effector of FIGS. 38and 39;

FIG. 41 is a cross-sectional view of the end effector of FIGS. 38-40;

FIG. 42 is a cut-away view of a portion of the end effector of FIGS.38-41;

FIG. 43 is a cross-sectional view of the end effector of FIGS. 38-42illustrating a needle in an advanced position;

FIGS. 44-46 are cut-away view of a portion of the end effector of FIGS.38-43 during different stages of operation;

FIG. 47 is a cross-sectional view of the end effector of FIGS. 38-46illustrating the needle in an advanced position;

FIG. 48 is a cross-sectional view of the end effector of FIGS. 38-47illustrating the needle in a retracted position;

FIG. 49 is a cross-sectional view of the end effector of FIGS. 38-48illustrating the needle in the retracted position and illustrating abarbed suture for use therewith;

FIG. 50 is a perspective view of an end effector in accordance withembodiments of the present disclosure;

FIG. 51 is an assembly view of the end effector of FIG. 50;

FIG. 52 is a perspective view of portions of the end effector of FIGS.50-51 shown with parts separated;

FIG. 53 is a cross-sectional view of the end effector of FIGS. 50-52;

FIG. 54 is a cross-sectional view of the end effector of FIGS. 50-53illustrating a needle in an advanced position;

FIG. 55 is an enlarged view of the area of detail indicated in FIG. 54;

FIG. 56 is a cross-sectional view of the end effector of FIGS. 50-55illustrating a needle in an advanced position;

FIG. 57 is an enlarged view of the area of detail indicated in FIG. 56;

FIG. 58 is a cross-sectional view of the end effector of FIGS. 50-57illustrating the needle in a retracted position and a suture that hasbeen ejected from the end effector;

FIG. 59 is a cross-sectional view of an end effector in accordance withembodiments of the present disclosure;

FIG. 60 is an assembly view of the end effector of FIG. 59;

FIG. 61 is a side view of a needle assembly of the end effector of FIGS.59-60;

FIG. 62 is a perspective view of the needle assembly of FIG. 61;

FIGS. 63 and 64 are perspective views of the end effector of FIGS. 59-62shown during different stages of operation;

FIG. 65 is a cross-sectional view of the end effector of FIGS. 59-64illustrating the needle assembly in an advanced position;

FIG. 66 is a perspective view of a distal portion of the end effector ofFIGS. 59-68 illustrating the needle assembly in an advanced position;and

FIG. 67 is a cut-away view of the end effector of FIGS. 59-66illustrating the needle assembly in a retracted position.

DETAILED DESCRIPTION OF EMBODIMENTS

Embodiments of the presently disclosed endoscopic surgical device isdescribed in detail with reference to the drawings, in which likereference numerals designate identical or corresponding elements in eachof the several views. As used herein the term “distal” refers to thatportion of the endoscopic surgical device that is farther from the user,while the term “proximal” refers to that portion of the surgical devicethat is closer to the user.

Non-limiting examples of surgical devices which may include articulationjoints according to the present disclosure include manual, mechanicaland/or electromechanical surgical tack appliers (i.e., tackers), clipappliers, surgical forceps, and the like.

Referring initial to FIGS. 1-4, a surgical instrument for use with thevarious end effectors of the present disclosure is generally designatedas surgical device 100. Surgical device 100 includes a handle assembly110, an elongated portion 120 extending distally from handle assembly110, an end effector 130 disposed in mechanical cooperation (e.g.,releasably engaged) with a distal portion of elongated portion 120, anda drive rod 150 disposed at least partially within elongated portion 120and configured to engage (e.g., releasably engage) end effector 130. Forclarity, FIGS. 1-3 illustrate a general end effector 130; various otherend effectors are shown and described throughout this application andare configured for use with surgical device 100. Generally, end effector130 is a separable component that is able to be used with a surgicalinstrument (e.g., a surgical fixation device handle). After its use(e.g., after one or more barbed sutures are released therefrom), the endeffector 130 can be removed from the remainder of the surgicalinstrument, and a new or reloaded end effector 130 can then engage thesurgical instrument and be used.

Handle assembly 110 includes a trigger or an actuator 112 (e.g., button,switch, etc.) thereon. In general, actuation of actuator 112 results inrotation of drive rod 150, e.g., in the general direction of arrow “A”in FIG. 4. There are a variety of ways surgical device 100 can transferthe movement caused by actuation of actuator 112 to rotation of driverod 150, such as those disclosed in U.S. patent application Ser. No.15/049,511, filed on Feb. 22, 2016, now U.S. Pat. No. 10,085,746, theentire contents of which are hereby incorporated by reference herein.

Several of the end effectors of the present disclosure are usable toadvance at least a portion of a needle and/or at least a portion of asuture (e.g., a barbed suture) or other fixation device into tissueand/or mesh, for instance. An example of a disclosed use of the endeffectors relates to positioning and/or fixation of laparoscopic ventralmesh. In such procedures, stay-sutures are typically tied to the cornersand/or cardinal points by surgeons. The mesh and sutures are then rolledand introduced through the trocar and into the laparoscopic workingspace. The mesh is then unrolled, and positioned into place. If thesutures have needles attached, care must be taken during rolling,insertion, unrolling and positioning to help ensure the needle points donot damage the mesh (especially if the mesh includes an adhesion barrierlayer) or to injure the patient or clinician. Once the mesh is properlyunrolled and placed against the abdominal wall in the correct location,the stay-sutures are delivered across the abdominal wall (either fromthe inside toward the outside using an attached needle, or from theoutside toward the inside using a suture passer introduced from outsidethe abdominal wall to grasp and pull the suture from the laparoscopicworking space). After the stay-sutures have all been inserted, theclinician can finish fixating the mesh to the abdominal wall with aseparate fixation device, such as a surgical tack applier.

The various end effectors disclosed herein help standardize surgicalprocedures (e.g., positioning and/or fixation of laparoscopic ventralmesh) and reduce the number of steps and time required to fixate themesh with stay-sutures. The needle assemblies of the present disclosureallow a surgeon to introduce and pass a stay-suture through the implantand abdominal wall without the need to pre-attach the stay-sutures toneedles, and without the risk of accidental needle sticks. The disclosedend effectors can used as a reload for use with standard surgical devicehandles to minimize the number of surgical devices (and the expense)needed for related surgical procedures.

Needle Styles

A variety of different types of needles may be used in combination withvarious embodiments of the present disclosure. While FIGS. 5-8illustrate several types of needles, other types of needles may be usedwith the various end effectors disclosed herein. FIG. 5 illustrates asingle needle 3000 a extending from a needle block 3002, and a barbedsuture 3010 a operatively engaged (e.g., releasably engaged) therewithsuch that needle 3000 a and barbed suture 3010 a are insertable into animplant/tissue, and barbed suture 3010 a remains in engagement with theimplant/tissue when needle 3000 a is retracted. A pledget 3003 a is alsoincluded adjacent proximal portions of needle 3000 a and barbed suture3010 a, which may releasably hold barbed suture 3010 a, and which mayact as a stop to help limit the distal advancement of barbed suture 3010a into the implant/tissue. A distal portion of barbed suture 3010 a maybe bent into a hollow cavity at a distal portion of needle 3000 a tohelp releasably retain barbed suture 3010 a in engagement with needle3000 a. FIG. 6 illustrates a pair of needles 3000 b disposed in aparallel relationship extending from needle block 3002, and a suture3010 b supported between needles 3000 b. Each needle of pair of needles3000 b extends distally from needle block 3002 in a direction that isperpendicular to a distal face 3002 b of needle block 3002 (e.g.,parallel to a longitudinal axis defined by an elongated portion ofsurgical device 100 engaged with needle block 3002). Pair of needles3000 b is sufficiently sturdy to support suture 3010 b therebetween. Adistal portion of suture 3010 b may be bent into a hollow cavity at adistal portion of needle 3000 b to help releasably retain suture 3010 bin engagement with needles 3000 b. It is envisioned that an adhesive isused to temporarily retain suture 3010 b in the illustrated position. Inuse, at least a portion of needles 3000 b and suture 3010 b are insertedinto/through an implant/tissue to emplace suture 3010 b through theimplant, for example. Suture 3010 b remains emplaced through the implantup retraction of needles 3000 b. Another suture 3010 b can then bepositioned between needles of pair of needles 3000 b to allow forrepeated use of pair of needles 3000 b. FIG. 7 illustrates a pair ofneedles 3000 c disposed in a bowed relationship extending from needleblock 3002, and a suture 3010 c supported between needles 3000 c.Needles 3000 c extend radially outward from each other, such that distalends 3002 c of needles 3000 c are farther apart than proximal ends 3004c of needles 3000 c. Pair of needles 3000 c is sufficiently sturdy tosupport suture 3010 c therebetween. A distal portion of suture 3010 cmay be bent into a hollow cavity at a distal portion of needle 3000 c tohelp releasably retain suture 3010 c in engagement with needles 3000 c.It is envisioned that an adhesive is used to temporarily retain suture3010 c in the illustrated position. FIG. 8 illustrates a pair of needles3000 d extending in an arcuate manner from needle block 3002, andsupporting a suture 3010 d at least partially therebetween. Further,distal portions of suture 3010 d are engaged with distal portions ofneedles 3000 d. A distal portion of suture 3010 d may be bent into ahollow cavity at a distal portion of needle 3000 d to help releasablyretain suture 3010 d in engagement with needles 3000 d. It is envisionedthat an adhesive is used to temporarily retain suture 3010 d in theillustrated position. Pair of needles 3000 d may be used when aclinician desires to secure a relatively wide portion of an implant ortissue, as the distal tips of needles 3000 d are positioned far awayfrom each other, with respect to pair of needles 3000 b and 3000 c. Itis envisioned that needles 3000 a, 3000 b, 3000 c and 3000 d are madefrom a shape memory material, such as nitinol.

Needle Tip Attachment

Several different ways of coupling needles with suture are usable withembodiments of end effectors disclosed herein and are illustrated inFIGS. 9-20. In FIG. 9, a needle 4010 is shown including a flange 4012projecting from a recess 4014 within a shaft of needle 4010. A distalend of flange 4012 may be able to move, flex or pivot away from recess4014. A barbed suture 4000 is releasably held by flange 4012. In use,distal advancement of needle 4010 towards (e.g., into) tissue causes acorresponding distal advancement of barbed suture 4000. When needle 4010is moved proximally or retracted, flange 4012 moves over or releasesbarbed suture 4000, thus leaving barbed suture 4000 within tissue, forexample.

In FIGS. 10-11, a needle 4020 is shown including an actuation suture4022 extending through needle 4020 between a recess 4024 within a shaftof needle 4020 and a proximal opening 4026 of needle 4020. A distalportion of actuation suture 4022 releasably holds barbed suture 4000. Inuse, distal advancement of needle 4020 towards (e.g., into) tissuecauses a corresponding distal advancement of barbed suture 4000. Whenactuation suture 4022 is moved proximally or retracted in the generaldirection of arrow “NTA,” distal portion of actuation suture 4022 movesin the general direction of arrow “NTB” or releases barbed suture 4000,thus leaving barbed suture 4000 within tissue, for example. It isenvisioned that a proximal portion of actuation suture 4022 is engagedwith an appropriate anchor portion of an end effector such thatadvancement of needle 4020 moves needle 4020 away from the anchorportion of the end effector, which causes a relative retraction ofactuation suture 4022.

In FIGS. 12-13, a needle 4030 is shown including a suture 4002 engagedwith a cavity 4032 of needle 4030. Cavity 4032 of needle 4030 includes afirst, proximal portion 4032 a and a second, distal portion 4032 b. Asshown, distal portion 4032 b of cavity 4032 is deeper than proximalportion 4032 a of cavity 4032. Distal portion 4032 b of cavity 4032 isconfigured to releasably engage an enlarged or ball portion 4002 a ofsuture 4002, and proximal portion 4032 a of cavity 4032 is configured toreleasably engage a body portion 4002 b of suture 4002. In use, distaladvancement of needle 4030 towards (e.g., into) tissue causes acorresponding distal advancement of suture 4002. When needle 4030 ismoved proximally or retracted, suture 4002 is able to slide in thegeneral direction of arrow “NTA” relative to needle 4030, thus leavingsuture 4002 within tissue, for example.

In FIGS. 14-15, a needle 4040 is shown including a proximal portion 4040a and a distal portion 4040 b. Proximal portion 4040 a and distalportion 4040 b of needle 4040 are releasably engaged with each other.Accordingly, moving proximal portion 4040 a proximally with respect todistal portion 4040 b, for example, can separate the two portions ofneedle 4040. A suture 4004 is engaged with a distal part of distalportion 4040 b of needle 4040. For example, a portion of suture 4004 isdisposed within a cavity 4042 of distal portion 4040 b of needle 4040.In use, distal advancement of needle 4040 towards (e.g., into) tissuecauses a corresponding distal advancement of suture 4004. When proximalportion 4040 a of needle 4040 is moved proximally or retracted, distalportion 4040 b of needle 4040 separates from proximal portion 4040 a,which results in distal portion 4040 b of needle 4040 and portions ofsuture 4004 remaining in tissue.

In FIG. 16, a needle 4050 is shown including an angled axial cut 4052disposed therein. Angled axial cut 4052 of needle 4050 is configured tofrictionally and releasably hold a portion of suture 4004 therein. Inuse, distal advancement of needle 4050 towards (e.g., into) tissuecauses a corresponding distal advancement of suture 4004. When needle4050 is moved proximally or retracted, portions of suture 4004 releasefrom angled axial cut 4052 and remain within tissue, for example. It isenvisioned that needle 4050 may be manufactured using an angled mill.

In FIG. 17, a needle 4060 is shown including a perpendicular axial cut4062 disposed therein. Perpendicular axial cut 4062 of needle 4060 isconfigured to frictionally and releasably hold a portion of suture 4004therein. In use, distal advancement of needle 4060 towards (e.g., into)tissue causes a corresponding distal advancement of suture 4004. Whenneedle 4060 is moved proximally or retracted, portions of suture 4004release from perpendicular axial cut 4062 and remain within tissue, forexample. It is envisioned that needle 4060 may be manufactured using acut off wheel.

In FIG. 18, a needle 4070 is shown including a lateral aperture 4072disposed therethrough. Lateral aperture 4072 of needle 4070 isconfigured to allow a portion of suture 4004 to be threadedtherethrough. In use, distal advancement of needle 4070 towards (e.g.,into) tissue causes a corresponding distal advancement of suture 4004.When needle 4070 is moved proximally or retracted, portions of suture4004 are removed from lateral aperture 4072 and remain within tissue,for example. It is envisioned that a pin or wire travels through needle4070 to sever suture 4004.

In FIGS. 19 and 20, a needle 4080 is shown including a slotted tip 4082.Slotted tip 4082 of needle 4080 is configured to frictionally andreleasably hold a portion of suture 4004 (FIG. 19) or multiple sutures(FIG. 20) therein. In use, distal advancement of needle 4080 towards(e.g., into) tissue causes a corresponding distal advancement ofsuture(s) 4004. When needle 4080 is moved proximally or retracted,portions of suture(s) 4004 are removed from slotted tip 4082 and remainwithin tissue, for example.

Spring Loaded Safety Cover

Referring now to FIGS. 21-33, an embodiment of an end effector 1000including a spring-loaded safety cover assembly is shown. End effector1000 is configured for use in connection with surgical device 100.Generally, end effector 1000 is configured to prevent unintentionalcontact with a needle and/or a barbed suture within or extendingdistally from its outer tube. While FIGS. 21-33 illustrate a particulartype of barbed suture 1002 and a particular type of needle 1006, endeffector 1000 may be used with different types of sutures and/orneedles.

With particular reference to FIGS. 21 and 22, end effector 1000 includesa cover 1010, a first biasing element or spring 1020, a clevis 1030, aclutch 1040, a drive element 1050, a second biasing element or spring1060 (FIG. 22), and an outer tube 1070.

Cover 1010 of end effector 1000 includes a cylindrical body portion1012, a pair of arms 1014 extending proximally from body portion 1012, alip 1016 extending radially inward from a proximal portion of each arm1014, and a tab 1018 extending radially outward from a proximal portionof one the arms 1014.

Clevis 1030 of end effector 1000 includes a body portion 1032, a pair ofarms 1034 extending distally from body portion 1032, a flange 1036extending radially outward from body portion 1032, and a plurality ofteeth 1038 disposed on a proximal end of body portion 1032. Firstbiasing element 1020 is positioned between arms 1034 of clevis 1030 andarms 1014 of cover 1010. Body portion 1032 of clevis 1030 engages aproximal end of first biasing element 1020; lips 1016 of cover 1010engage a distal end of first biasing element 1020.

A proximal portion 1007 of needle 1006 is positioned radially inward ofbody portion 1032 of clevis 1030. Further, flat portions 1007 a (seeFIG. 28) of proximal portion 1007 of needle 1006 engage correspondingflat portions 1037 of body portion 1032 of clevis 1030, thus limiting orpreventing rotation therebetween. Needle 1006 also includes a distal tip1008 and a hook 1009. Distal tip 1008 of needle 1006 is configured topierce tissue, and hook 1009 of needle 1006 is configured to engage aportion of barbed suture 1002.

Clutch 1040 of end effector 1000 includes a body portion 1042, aplurality of teeth 1044 disposed on a distal end of body portion 1042,and a proximal surface 1046. Teeth 1044 of clutch 1040 are configured toengage teeth 1038 of clevis 1030.

Drive element 1050 of end effector 1000 is mechanically engaged (e.g.,operatively coupled, directly affixed, etc.) to drive rod 150 ofsurgical device 100 of the present disclosure. Drive element 1050includes a proximal end 1052, a distal end 1054, and a groove 1056.Groove 1056 of drive element 1050 is configured to engage a shippingwedge (not shown) to help lock drive element 1050 in place with respectto outer tube 1070, for example. Proximal end 1052 of drive element 1050is configured to engage the drive rod. Distal end 1054 of drive element1050 is mechanically engaged with second biasing element 1060. Proximalsurface 1046 of clutch 1040 is positioned to engage second biasingelement 1060. That is, second biasing element 1060 is positioned betweenproximal surface 1046 of clutch 1040 and distal end 1054 of driveelement 1050.

Outer tube 1070 of end effector 1000 includes a proximal notch 1072, acutout 1074, and a longitudinal groove 1076 having an angled slot 1078extending therefrom. Outer tube 1070 is configured for positioningradially outward of, and to at least partially contain, at leastportions of barbed suture 1002, needle 1006, cover 1010, first biasingelement 1020, clevis 1030, clutch 1040, drive element 1050, and secondbiasing element 1060.

As shown in FIG. 23, prior to use, a portion of proximal notch 1072 islongitudinally aligned with groove 1056 of drive element 1050 such thata shipping wedge (not shown) can extend through proximal notch 1072 andinto engagement with groove 1056. The engagement between drive element1050, second biasing element 1060, clutch 1040, and clevis 1030 is alsoshown in FIG. 23. As shown, second biasing element 1060 is disposedbetween drive element 1050 and clutch 1040, thus transferring rotationalmovement from drive element 1050 (and drive rod 150, as discussed above)to clutch 1040. Additionally, second biasing element 1060 enacts adistal force onto clutch 1040 to help maintain engagement between teeth1044 of clutch 1040 and teeth 1038 of clevis 1030. Accordingly, rotationof clutch 1040 results in a corresponding rotation of clevis 1030.

With particular reference to FIG. 24, prior to use, tab 1018 of cover1010 of end effector 1000 is disposed within angled slot 1078 oflongitudinal groove 1076 of outer tube 1070. The engagement between tab1018 and angled slot 1078 prevents cover 1010 from distally advancingwith respect to outer tube 1070. In this position, cover 1010 is in itsdistal-most position where it radially surrounds distal tip 1008 ofneedle 1006 and barbed suture 1002.

In use, in response to at least a partial actuation of the trigger, thedrive rod 150 rotates, as discussed above. Rotation of the drive rodresults in a corresponding rotation of drive element 1050, clutch 1040,and clevis 1030. A predetermined amount of rotation (e.g., about) 90° ofclevis 1030 causes flange 1036 of clevis 1030 to rotate in the generaldirection of arrow “FLA” from a first position within cutout 1074 ofouter tube 1070, to a second position where flange 1036 engages alateral wall 1074 a of cutout 1074 of outer tube 1070 (see FIG. 27).Engagement between flange 1036 and lateral wall 1074 a preventscontinued rotation of clevis 1030 with respect to outer tube 1070 in thedirection of arrow “FLA.” Accordingly, when clevis 1030 continues torotate in the direction of arrow “FLA” (e.g., in response to continuedor additional actuation of the trigger), outer tube 1070 also rotates inthe direction of arrow “FLA” with respect to cover 1010.

Rotation of outer tube 1070 in the direction of arrow “FLA” with respectto cover 1010 causes angled slot 1078 of outer tube 1070 to disengagefrom tab 1018 of cover 1010, which causes tab 1018 of cover 1010 to bewithin longitudinal groove 1076 of outer tube 1070. When tab 1018 ofcover 1010 is within longitudinal groove 1076 of outer tube 1070, cover1010 is in an unlocked position.

Next, a user presses a distal tip of surgical device 100 against tissueand/or mesh to emplace barbed suture 1002 at least partially thereinand/or therethrough. More particularly, the user pushes a distal edge1010 a of cover 1010 against the tissue/mesh, which causes cover 1010 tomove proximally with respect to outer tube 1070 against the bias offirst biasing element 1020. As cover 1010 moves proximally, tab 1018 ofcover 1010 travels proximally within longitudinal groove 1076 of outertube 1070. The proximal movement of cover 1010 exposes barbed suture1002 and distal tip 1008 of needle 1006, at least portions of whichextend distally beyond outer tube 1070, and enables barbed suture 1002and distal tip 1008 to penetrate the tissue/mesh.

As the user moves the surgical device 100 proximally (e.g., after barbedsuture 1002 has been emplaced in tissue/mesh), first biasing element1020 urges cover 1010 distally with respect to outer tube 1070. Cover1010 continues to move distally while tab 1018 of cover 1010 travelswithin longitudinal groove 1076 of outer tube 1070 until tab 1018contacts a distal edge 1076 a of longitudinal groove 1076, preventingfurther distal movement of cover 1010 with respect to outer tube 1070(see FIGS. 31 and 32). Further, as tab 1018 of cover 1010 contactsdistal edge 1076 a of longitudinal groove 1076, at least one proximalfinger 1019 of cover 1010 enters an aperture 1071 of outer tube 1070(e.g., in response to a radial outward bias of arms 1014), thuseffectively locking the longitudinal position of cover 1010 with respectto outer tube 1070 (see FIGS. 31 and 33).

Folding Safety Cover

With reference to FIGS. 34-37, a safety cover assembly 2800 for use withvarious end effectors disclosed herein is shown. A cover 2810 of safetycover assembly 2800 is configured to pivot between a first positionwhere safety cover 2800 helps prevent unintentional contact with aneedle 2806 (FIG. 34), and a second position where safety cover 2800allows needle 2806 to be driven into tissue (FIG. 35).

With particular reference to FIG. 37, safety cover assembly 2800includes cover 2810, a drive member 2820, a biasing member 2830, a gear2840, a clutch 2850, and an outer tube 2870. Cover 2810 includes aproximal lip 2812, and an angled blocking portion 2814 (FIG. 36).Proximal lip 2812 is configured to pivotably engage a distal finger 2872of outer tube 2870 to facilitate pivotal movement therebetween. Blockingportion 2814 of cover 2810 is configured to selectively engage a portionof needle 2806 and/or clutch 2850. The engagement between blockingportion 2814 and needle 2806 and/or clutch 2850 restricts the biasingforce supplied by biasing member 2830.

Biasing member 2830 of cover assembly 2800 includes a first portion 2832engaged with (e.g., affixed to) a proximal portion of needle 2086, and asecond portion 2834 engaged with (e.g., affixed to) a proximal portionof cover 2810. Biasing member 2830 is configured to bias cover 2810 awayfrom needle 2806 toward its second position (FIG. 35). As noted above,the engagement between blocking portion 2814 of cover 2810 and needle2806 and/or clutch 2850 resists the biasing force supplied by biasingmember 2830.

Drive member 2820, gear 2840, and clutch 2850 of cover assembly 2800 aredisposed radially within outer tube 2870. Drive member 2820 ismechanically engaged (e.g., operatively coupled, directly affixed, etc.)to drive rod 150 of surgical device 100 of the present disclosure.Accordingly, rotation of the drive rod 150 in the general direction ofarrow “FSA” results in a corresponding rotation of drive member 2820.Additionally, drive member 2820 is configured to engage gear 2840 suchthat rotation of drive member 2820 in the general direction of arrow“FSA” causes a corresponding rotation of gear 2840 in the generaldirection of arrow “FSA.” Further, gear 2840 is configured to engageclutch 2850 such that rotation of gear 2840 in the general direction ofarrow “FSA” causes a corresponding rotation of clutch 2850.

With reference to FIGS. 35-37, clutch 2850 of cover assembly 2800 isconfigured to engage a portion of cover 2810, such that rotation ofclutch 2850 in the general direction of arrow “FSA” causes acorresponding rotation of cover 2810 in the general direction of arrow“FSA.” With particular reference to FIG. 36, rotation of cover 2810 inthe general direction of arrow “FSA” causes blocking portion 2814 ofcover 2810 to rotate with respect to needle 2806, such that blockingportion 2814 no longer resists the force exerted by biasing member 2830onto cover 2810. Accordingly, rotation of drive rod 150 in the generaldirection of arrow “FSA” causes a corresponding rotation of drive member2820, gear 2840, clutch 2850 and cover 2810, thus causing cover 2810 topivot in the general direction of arrow “FSB” (FIG. 35) toward itssecond position, since blocking portion 2814 no longer resists the forceexerted by biasing member 2830 onto cover 2810. Additionally, proximalteeth 2852 of clutch 2850, which mate with distal teeth 2842 of gear2840, are configured to skip following additional rotation of gear 2840after cover 2810 moves toward its second position.

When cover 2810 is in its second position, needle 2806 is exposed and isable to be driven into tissue, for example. If a user desires to movecover 2810 back toward its first position, the user may use a secondaryinstrument or the user's hand, to pivot cover 2810 toward its firstposition against the bias of biasing member 2830. The cover 2810 can berotated in the general direction of arrow “FSC” (FIG. 35) such thatblocking portion 2814 engages needle 2806 and resists the force exertedby biasing member 2830.

Preloaded Spring

Referring now to FIGS. 38-49, an embodiment of an end effector 1100including a pre-loaded spring assembly is shown. End effector 1100 isconfigured for use in connection with surgical device 100. Generally,end effector 1100 is configured to advance a needle 1106 and to eject abarbed suture 1102 towards tissue. While FIGS. 38-49 illustrate aparticular type of barbed suture 1102 and a particular type of needle1106, end effector 1100 may be used with different types of suturesand/or needles.

With particular reference to FIG. 39, end effector 1100 includes a driveassembly 1110, a proximal stop 1120, a distal stop 1130, a helix or coil1140, a first biasing element 1150, a second biasing element 1160, apair of rings 1165, and an outer tube 1170.

Drive assembly 1110 of end effector 1100 is mechanically engaged (e.g.,operatively coupled, directly affixed, etc.) to drive rod 150 ofsurgical device 100 of the present disclosure. Drive assembly 1110includes a proximal portion 1112, a body portion 1114, members 1116, afirst arm 1118 extending distally from body portion 1114, and a secondarm 1119 extending distally from body portion 1114.

Proximal stop 1120 of end effector 1100 is positioned radially outwardof body portion 1114 of drive assembly 1110, and includes a body portion1122, and a finger 1124. Finger 1124 extends radially inward from bodyportion 1122, is movable in a radially outward direction with respect tobody portion 1122, and may be biased radially inward. As discussedbelow, finger 1124 is configured to move between its first, radiallyinward position (FIG. 40) toward its second, radially outward position(FIG. 42) in response to contact by first arm 1118 and/or second arm1119 of drive assembly 1110. Members 1116 of drive assembly 1110 areconfigured to retain the longitudinal position of drive assembly 1110 bybeing positioned proximally of a first ring 1165 a and distally of asecond ring 1165 b (see FIG. 38).

Distal stop 1130 of end effector 1100 is positioned radially outward ofat least part of first arm 1118 of drive assembly 1110, and includes abody portion 1132, a protrusion 1134 extending radially inward from bodyportion 1132, and a helical groove 1136 disposed within body portion1132. With particular reference to FIGS. 44-46, protrusion 1134 ofdistal stop 1130 includes a first stop surface 1134 a and a second stopsurface 1134 b, which are each configured to engage first arm 1118 ofdrive assembly 1110. Additionally, distal stop 1130 is rotationallysupported within outer tube 1170.

Helix or coil 1140 of end effector 1100 extends between proximal stop1120 and distal stop 1140 and radially within outer tube 1170. Helix orcoil 1140 is stationary with respect to outer tube 1170, and isconfigured to engage helical groove 1136 of distal stop 1130 such thatdistal stop 1130 can move longitudinally and rotationally within outertube 1170 and with respect to outer tube 1170.

Needle 1106 is disposed radially inward of drive assembly 1110, andincludes a body portion 1106 a, a proximal extension 1106 b extendingproximally from body portion 1106 a, an elongated portion 1106 c, a hook1106 d, and a distal tip 1106 e. Body portion 1106 a is configured tomove longitudinally within outer tube 1170 and with respect to outertube 1170. Distal tip 1106 e of needle 1106 is configured to piercetissue, and hook 1106 d of needle 1106 is configured to engage a portionof barbed suture 1102.

First biasing element 1150, e.g., a compression spring, of end effector1100 includes a proximal portion 1152 and a distal portion 1154.Proximal portion 1152 of first biasing element 1150 is positioned withinbody portion 1114 of drive assembly 1110. Distal portion 1154 of firstbiasing element 1150 is positioned radially outward of proximalextension 1106 b of needle 1106. A distal end 1156 of first biasingelement 1150 is positioned in contact with a proximal surface 1106 aa ofbody portion 1106 a of needle 1106. First biasing element 1150 isconfigured to bias needle 1106 distally with respect to outer tube 1170.

Second biasing element 1160, e.g., a compression spring, of end effector1100 includes a proximal portion 1162 and a distal portion 1164.Proximal portion 1162 of second biasing element 1160 is positionedwithin body portion 1114 of drive assembly 1110. Distal portion 1164 ofsecond biasing element 1160 is positioned proximally of proximalextension 1106 b of needle 1106. A distal end 1166 of second biasingelement 1160 is positioned in contact with a proximal surface 1106 ba ofproximal extension 1106 b of needle 1106. Second biasing element 1160 isconfigured to bias needle 1106 distally with respect to outer tube 1170.

Rings 1165 (e.g., O-rings) of end effector 1100 are positioned radiallyoutward of proximal body portion 1112 of drive assembly 1110. Rings 1165help maintain appropriate spacing between drive assembly 1110 and outertube 1170, and help facilitate rotation of drive assembly 1110 withrespect to outer tube 1170.

Outer tube 1170 of end effector 1100 includes a proximal notch 1172, anda lip 1174 extending radially inward from a distal end of outer tube1170. Outer tube 1170 is configured for positioning radially outward of,and for at least partially retaining, at least portions of barbed suture1102, needle 1106, drive assembly 1110, proximal stop 1120, distal stop1130, helix or coil 1140, first biasing element 1150, second biasingelement 1160, and pair of rings 1165.

As shown in FIG. 40, prior to use, finger 1124 of proximal stop 1120 isin contact with a distal face 1106 ab of body portion 1106 a of needle1106. This contact between finger 1124 and needle 1106 resists thedistal bias of first biasing element 1150 and second biasing element1160, and thus prevents needle 1106 from distally translating withrespect to outer tube 1170.

In use, in response to at least a partial actuation of the trigger 112of surgical device 100, drive rod 150 of surgical device 100 rotates, asdiscussed above. With reference to FIGS. 40-42, rotation of drive rod150 results in a corresponding rotation of drive assembly 1110 of endeffector 1100 with respect to outer tube 1170 and with respect toproximal stop 1120. A predetermined amount of rotation (e.g., about 90°)of drive assembly 1110 causes cam member 1116 of drive assembly 1110 torotate in the general direction of arrow “CMA” (FIG. 42) from a firstposition where first arm 1118 and second arm 1119 are free from contactwith finger 1124 of proximal stop 1120, to a second position where firstarm 1118 and/or second arm 1119 engage(s) finger 1124. Engagementbetween first arm 1118 or second arm 1119 and finger 1124 causes finger1124 to flex radially outward in the general direction of arrow “FA” inFIG. 42. Once finger 1124 has flexed or moved radially outward, finger1124 no longer resists the distal bias of first biasing element 1150 andsecond biasing element 1160, thus resulting in needle 1106 distallytranslating with respect to outer tube 1170.

As needle 1106 travels distally, a distal portion of needle 1106 (e.g.,distal tip 1106 e) and barbed suture 1102 distally exit outer tube 1170,and engage tissue/mesh, for instance. Distal movement of needle 1106with respect to outer tube 1170 continues until distal face 1106 ab ofbody portion 1106 a of needle 1106 contacts a proximal edge 1138 ofdistal stop 1130. Engagement between needle 1106 and distal stop 1130resists the distal bias of first biasing element 1150 and second biasingelement 1160, thus resulting in needle 1106 ceasing its distal travelwith respect to outer tube 1170.

Additionally, and with reference to FIGS. 41 and 43-46, after driveassembly 1110 of end effector 1100 initially rotates (e.g., about 90°)and engages finger 1124 of proximal stop 1120, drive assembly 1110continues to rotate (e.g., up to about 270°), and first arm 1118 thereofalso rotates (in the general direction of arrow “FAB” in FIGS. 45 and46) until first arm 1118 contacts second stop surface 1134 b ofprotrusion 1134 of distal stop 1130. Continued rotation of driveassembly 1110, and thus its first arm 1118, causes a correspondingrotation of distal stop 1130 in the general direction of arrow “FAB.”

Referring now to FIGS. 47-49, the engagement between helical groove 1136of distal stop 1130 and helix or coil 1140 causes rotation of distalstop 1130 in the general direction of arrow “FAB” (FIGS. 45 and 46)causes distal stop 1130 to move proximally with respect to outer tube1170 in the general direction of arrow “DSA” (FIG. 48). As additionallyshown, proximal movement of distal stop 1130 results in a correspondingproximal movement of needle 1106 due to the engagement between distalstop 1130 and distal face 1106 ab of body portion 1106 a of needle 1106.Needle 1106 is movable proximally until its distal tip 1106 e islongitudinally aligned with or proximal of a distal end of outer tube1170, thereby reducing the possibility of a user unintentionallycontacting needle 1106.

Swing Lock Helix Drive

Referring now to FIGS. 50-58, an embodiment of an end effector 2300 isshown. End effector 2300 is configured for use in connection withsurgical device 100. Generally, end effector 2300 is configured toadvance a suture 2302 and a needle assembly including needle 2306towards tissue. While FIGS. 50-58 illustrate a particular type of suture2302 and needle 2306, end effector 2000 may be used with different typesof sutures (e.g., barbed sutures) and needles.

With particular reference to FIG. 51, end effector 2300 includes adriver 2310, a drive assembly 2320, a spring 2330, an end cap 2340, alock 2350, a ring 2360, pins 2365, and an outer tube 2370.

Drive assembly 2320 of end effector 2300 is mechanically engaged (e.g.,operatively coupled, directly affixed, etc.) to drive rod 150 ofsurgical device 100 of the present disclosure. Rotation of the drive rod150 in the general direction of arrow “SLA” in FIG. 54 results in acorresponding rotation of drive assembly 2320. Drive assembly 2320includes an aperture 2322 (FIG. 53), a proximal recess 2323, and a bodyportion 2324 including a helical groove 2326. Aperture 2322 of driveassembly 2320 is configured to engage the drive rod 150 of the surgicaldevice 100. Proximal recess 2323 of drive assembly 2320 is configured torotationally engage pins 2365, which extend through apertures of outertube 2370 such that drive assembly 2320 is longitudinally fixed withrespect to outer tube 2370. Helical groove 2326 of drive assembly 2320is configured to rotationally engage an engagement structure 2314 ofdriver 2310. Additionally, ring 2360 of end effector 2300 is fixed todrive assembly 2320.

Driver 2310 of end effector 2300 includes a body portion 2312,engagement structure 2314 disposed at a proximal portion of body portion2312, a pair of longitudinal slots 2316 extending therethrough, and adistal slot 2318. Engagement structure 2314 of driver 2310 is configuredto engage helical groove 2326 of drive assembly 2320. While engagementstructure 2314 is illustrated as a helical thread, engagement structure2314 may also be a pin or the like. Due to the engagement betweenengagement structure 2314 and helical groove 2326 of drive assembly2320, rotation of drive assembly 2320 results in longitudinaltranslation of driver 2310. Longitudinal slots 2316 of driver 2310 areconfigured to slidingly receive a pin 2372, such that pin 2372 helpsguide longitudinal translation of driver 2310 with respect to outer tube2370. Distal slot 2318 of driver 2310 is configured to allow a portionof lock 2350 to pass therethrough.

Biasing element or spring 2330 (e.g., a compression spring) of endeffector 2300 is disposed proximally of and in contact with a proximalface 2342 of end cap 2340, and distally of and in contact with aproximal base 2306 a of needle 2306. Spring 2330 is configured to biasneedle 2306 proximally with respect to outer tube 2370.

End cap 2340 of end effector 2300 is disposed radially within outer tube2370 and includes proximal face 2342, a body portion 2344, a distal lip2346, and a groove 2348. With particular reference to FIG. 55, a distalend of driver 2310 of end effector 2300 is configured to be positionedradially outward of body portion 2344 of end cap 2340, and a distal-mostedge 2312 a of body portion 2312 of driver 2310 is configured to abutdistal lip 2346 of end cap 2340. Groove 2348 of end cap 2340 includes afirst section 2348 a configured to slidingly receive a portion of needle2306, and a second section 2348 b configured to receive a portion oflock 2350.

Lock 2350 of end effector 2300 is pivotable or rotatable at leastpartially within second section 2348 b of groove 2348 with respect toend cap 2340. Moreover, lock 2350 is pivotable between a first position(FIG. 55) where an entirety of lock 2350 is disposed radially inward ofouter tube 2370, and a second position (FIG. 57) where a portion of lock2350 extends through distal slot 2318 of driver 2310 and through adistal slot 2374 of outer tube 2370 such that a portion of lock 2350 isdisposed radially outward of outer tube 2370.

In its first position, a contact portion 2352 of lock 2350 is configuredto engage, abut or contact a hub 2306 b of needle 2306. The proximalforce exerted by spring 2330 on needle 2306 causes needle 2306 to exerta proximal force on lock 2350, which would cause lock 2350 to pivotabout a lock pin 2354 in the general direction of arrow “SLB” in FIG.55. However, the engagement between a blocking portion 2356 of lock 2350and an inner wall of outer tube 2370 prevents lock 2350 from pivotingtowards its second position. Thus, the engagement between lock 2350 andproximal hub 2306 b of needle 2306 prevents spring 2330 from movingneedle 2306 proximally with respect to end cap 2340.

With particular reference to FIG. 57, in response to a predeterminedamount of distal travel of driver 2310 of end effector 2300 and end cap2340 of end effector 2300, lock 2350 is able to move toward its secondposition. That is, after driver 2310 and end cap 2340 have been distallyadvanced into a position where blocking portion 2356 of lock 2350 isaxially aligned with distal slot 2374 of outer tube 2370, the inner wallof outer tube 2370 no longer resists the pivoting force exerted byspring 2330 onto lock 2350. Thus, lock 2350 is able to pivot in thegeneral direction of arrow “SLB” such that a portion of lock 2350extends through distal slot 2374 of outer tube 2370. Here, contactportion 2352 of lock 2350 is no longer in engagement with proximal hub2306 b of needle 2306. Accordingly, the proximal force exerted by spring2330 onto needle 2306 is no longer opposed, and needle 2306 translatesproximally with respect to outer tube 2370.

Ring 2360 (e.g., an O-ring) of end effector 2300 is positioned radiallyoutward of a proximal portion of drive assembly 2320. Ring 2360 helpsmaintain appropriate spacing between drive assembly 2320 and outer tube2370, and helps facilitate rotation of drive assembly 2320 with respectto outer tube 2370.

Outer tube 2370 of end effector 2300 is configured for positioningradially outward of at least portions of suture 2302, needle 2306,driver 2310, drive assembly 2320, spring 2330, end cap 2340, lock 2350,and ring 2360.

In use, in response to at least a partial actuation of the trigger 112of surgical device 100, the drive rod 150 rotates, as discussed above.With reference to FIGS. 54-55, initial rotation of the drive rod 150results in a corresponding rotation of drive assembly 2320 of endeffector 2300 with respect to outer tube 2370 of end effector 2300 inthe general direction of arrow “SLA” in FIG. 54. Due to the engagementbetween helical groove 2326 of drive assembly 2320 and engagementstructure 2314 of driver 2310, rotation of drive assembly 2320 in thegeneral direction of arrow “LSA” results in distal translation of driver2310 with respect to outer tube 2370 in the general direction of arrow“SLC” in FIG. 54. Distal translation of driver 2310 causes acorresponding distal translation of end cap 2340, lock 2350, needle 2306and suture 2302.

Continued rotation of drive assembly 2320 in the general direction ofarrow “SLA” causes continued distal advancement of driver 2310, end cap2340, lock 2350, needle 2306 and suture 2302 until a distal tip 2306 cof needle 2300 extends a sufficient distance distally beyond a distalend of outer tube 2370. Thus, to insert needle 2306 into tissue, adistal end of end effector 2300 is positioned adjacent or in contactwith tissue, and the trigger of surgical device 100 is actuated (e.g., afull actuation of the trigger), thus distally advancing a portion ofneedle 2306 into tissue.

With particular reference to FIGS. 56 and 57, after a predeterminedamount of rotation of drive assembly 2320 and distal travel of driver2310, end cap 2340, lock 2350, needle 2306 and suture 2302 (e.g.,corresponding to when distal tip 2306 c is sufficiently advanced withintissue), blocking portion 2356 of lock 2350 is axially aligned withdistal slot 2374 of outer tube 2370, which allows lock 2350 to pivottoward its second position (FIG. 57). In this position, lock 2350 nolonger resists the proximal force exerted by spring 2330 on needle 2306,thus permitting needle 2306 to move proximally with respect to outertube 2370 in the general direction of arrow “SLD” in FIG. 58. That is,since the proximal force exerted by spring 2330 is no longer opposed bythe engagement between lock 2350 and outer tube 2370, needle 2306 isable to move proximally in the general direction of arrow “SLD” untilneedle 2306 reaches the approximate position shown in FIG. 58. As shown,suture 2302 remains outside of end effector 2300 (e.g., at leastpartially within tissue).

Stored Energy Spring

Referring now to FIGS. 59-67, an embodiment of an end effector 2700including a pre-loaded spring assembly is shown. End effector 2700 isconfigured for use in connection with surgical device 100. Generally,end effector 2700 is configured to advance needles 2706 and to eject abarbed suture 2702 towards tissue. While FIGS. 59-67 illustrate aparticular type of barbed suture 2702 and a particular type of needle2706, end effector 2700 may be used with different types of suturesand/or needles.

With particular reference to FIG. 60, end effector 2700 includes a driveassembly 2710, a needle assembly 2720, a biasing element 2730, a helixor coil assembly 2740, a pair of rings 2765, and an outer tube 2770.

Drive assembly 2710 of end effector 2700 is mechanically engaged (e.g.,operatively coupled, directly affixed, etc.) to drive rod 150 ofsurgical device 100 of the present disclosure. Drive assembly 2710includes a proximal portion 2712, a body portion 2714, and a pair ofarms 2716 extending distally from body portion 2714.

Needle assembly 2720 of end effector 2700 includes a body portion 2722,a pair of grooves 2724 extending longitudinal through body portion 2722,and a pin 2726 extending laterally through body portion 2722. Needles2706 extend distally from body portion 2722 and support (e.g.,frictionally support) barbed suture 2702 therebetween.

Biasing element 2730, e.g., a compression spring, of end effector 2700includes a proximal portion 2732 and a distal portion 2734. Proximalportion 2732 of biasing element 2730 is positioned in contact with(e.g., engaged with or affixed to) a distal end of body portion 2714 ofdrive assembly 2710. Distal portion 2734 of biasing element 2730 ispositioned in contact with (e.g., engaged with or affixed to) a proximalend of needle assembly 2720. Biasing element 2730 is configured to biasneedle assembly 2720, needles 2706 and barbed suture 2702 distally withrespect to outer tube 2770.

Helix or coil assembly 2740 of end effector 2700 is generallycylindrical in shape, and is hollow. Helix or coil assembly 2740includes a pair of longitudinal slots 2742 extending from a proximal end2740 a of helix or coil assembly 2740 toward a distal end 2740 b ofhelix or coil assembly 2740. Each longitudinal slot 2742 of helix orcoil assembly 2740 is configured to slidingly engage a portion of pin2726 extending through needle assembly 2720, such that needle assembly2720 is longitudinally translatable with respect to helix or coilassembly 2740. Helix or coil assembly 2740 also includes a helicalthread 2744 configured to rotationally engage a helical groove 2772 ofouter tube 2770, such that helix or coil assembly 2740 is rotatable andlongitudinally translatable with respect to outer tube 2770.

Rings 2765 (e.g., O-rings) of end effector 2700 are positioned radiallyoutward of portions of drive assembly 2710. Rings 2765 help maintainappropriate spacing between drive assembly 2710 and outer tube 2770, andhelp facilitate rotation of drive assembly 2710 with respect to outertube 2770.

Outer tube 2770 of end effector 2700 is configured for positioningradially outward of at least portions of barbed suture 2702, needles2706, drive assembly 2710, needle assembly 2720, biasing element 2730,helix or coil assembly 2740, and pair of rings 2765. Helical groove 2772of outer tube 2770 is configured to rotationally engage helix or coilassembly 2740, such that helix or coil assembly 2740 is rotatable andlongitudinally translatable with respect to outer tube 2770.

As shown in FIG. 63, prior to use, pin 2726 of needle assembly 2720 isin contact with proximal end 2740 a of helix or coil assembly 2740. Thiscontact between pin 2726 and helix or coil assembly 2740 resists thedistal bias of biasing element 2730, and thus prevents needle assembly2720 from distally translating with respect to outer tube 2770.Additionally, in its initial position, helix or coil assembly 2740 isdisposed at a distal position with respect to outer tube 2770, andhelical thread 2744 of helix or coil assembly 2740 is engaged withhelical groove 2772 of outer tube 2770.

In use, in response to at least a partial actuation of the trigger 112of surgical device 100, drive rod 150 of surgical device 100 rotates, asdiscussed above. With reference to FIGS. 63-66, initial rotation of thedrive rod 150 results in a corresponding rotation of drive assembly 2710with respect to outer tube 2770 and with respect to helix or coilassembly 2740. Rotation of drive assembly 2710 with respect to outertube 2770 causes a corresponding rotation of needle assembly 2720 withrespect to outer tube 2770 due to the engagement between arms 2716 ofdrive assembly 2710 and grooves 2724 of needle assembly 2720. Apredetermined amount of rotation (e.g., about 90°) of drive assembly2770, and thus needle assembly 2720, in the general direction of arrow“SEA” (FIG. 63) causes pin 2724 of needle assembly 2720 to rotate alongproximal end 2740 a of helix or coil assembly 2740 until pin 2724 isaligned with longitudinal slots 2742 of helix or coil assembly 2740.

In this position, where pin 2724 is aligned with longitudinal slots2742, pin 2724 is no longer in contact with proximal end 2740 a of helixor coil assembly 2740, thus there is nothing significantly resisting thedistally-directed force of biasing element 2730. Accordingly, biasingelement 2730 forces needle assembly 2720 to move distally with respectto helix or coil assembly 2740, guided by the engagement between pin2724 and longitudinal slots 2742 (see FIG. 64).

As needle assembly 2720 and needles 2706 travel distally, a distalportion of needles 2706 (e.g., distal tip 2706 a) and barbed suture 2702distally exit outer tube 2770, and engage tissue/mesh, for instance.Distal movement of needle assembly 2720 and needles 2706 with respect toouter tube 2770 continues until pin 2724 contacts distal ends 2742 a(FIG. 66) of longitudinal slots 2742. Engagement between pin 2724 anddistal ends 2742 a of longitudinal slots 2742 resists the distal bias ofbiasing element 2730, thus resulting in needle assembly 2720 and needles2706 ceasing their distal travel with respect to outer tube 2770.

Additionally, and with reference to FIGS. 65-67, after drive assembly2710 initially rotates (e.g., about 90°) and causes needle assembly 2720and needles 2706 to travel distally (as discussed above), drive assembly2710 continues to rotate (e.g., up to about 270°) in the generaldirection of arrow “SEA” in response to continued actuation of thetrigger 112, for example. Continued rotation of drive assembly 2710causes a corresponding rotation of needle assembly 2720 and pin 2724with respect to outer tube 2770. Rotation of needle assembly 2720 nowcauses a corresponding rotation of helix or coil assembly 2740 due tothe engagement between needle 2724 and a sidewall 2742 b of longitudinalslot 2742.

Moreover, when helix or coil assembly 2740 rotates with respect to outertube 2770, the engagement between helical thread 2744 of helix or coilassembly 2740 and helical groove 2772 of outer tube 2770 causes helix orcoil assembly 2740 to move proximally with respect to outer tube 2770 inthe general direction of arrow “SEB” in FIG. 67. Due to the engagementbetween distal ends 2742 a of longitudinal slots 2742 of helix or coilassembly 2740 and pin 2724 of needle assembly 2720, proximal movement ofhelix or coil assembly 2740 also causes a corresponding proximalmovement of needle assembly 2720. Needle assembly 2720 and needles 2706are movable proximally until distal tips 2706 a of needles 2706 arelongitudinally aligned with or proximal of a distal end of outer tube2770, thereby reducing the possibility of a user unintentionallycontacting needles 2706.

While some embodiments of end effectors described herein have beendescribed as being re-usable, it is contemplated that any of the endeffectors described herein are configured for release, reloading and/orreuse.

In accordance with the present disclosure, it is contemplated that anelectromechanical control module may replace handle assembly 110 toactuate the surgical device 100. The electromechanical control modulemay include at least one microprocessor, at least one drive motorcontrollable by the at least one microprocessor, and a source of powerfor energizing the at least one microprocessor and the at least onedrive motor.

As can be appreciated, securement of any of the components of thepresently disclosed devices can be effectuated using known fasteningtechniques such welding, crimping, gluing, etc.

Additionally, the present disclosure includes methods of using thedisclosed end effectors, and methods of performing a surgical procedureutilizing the disclosed end effectors. An example of a disclosed methodincludes using a disclosed end effector to advance stay-sutures (e.g.,four stay-sutures) through an implant (e.g., mesh) to hold the implantin a desired position, removing the end effector from the handle portionof a surgical instrument, engaging a second end effector with the samehandle portion of the surgical instrument used to advance stay-suturesthrough the implant, and advancing tacks from the second end effectorthrough the implant.

The present disclosure also includes surgical systems. A disclosedsurgical system includes a surgical device, a first end effector and asecond end effector. The surgical device includes a handle assembly andan elongated portion extending distally from the handle assembly. Thefirst end effector is configured to releasably engage a distal portionof the elongated portion, and includes a drive assembly and a needleassembly. The drive assembly is configured to advance and retract theneedle assembly upon at least a partial actuation of the handle assemblyof the surgical device. The second end effector is configured toreleasably engage the distal portion of the elongated portion, includesa plurality of tacks therein, and is configured to distally advance theplurality of tacks upon at least a partial actuation of the handleassembly of the surgical device.

The present disclosure also includes surgical kits including a pluralityof first end effectors (e.g., pre-loaded with stay-sutures, barbedsutures, etc.), a plurality of second end effectors (e.g., pre-loadedwith a plurality of tacks), and a surgical device. The surgical deviceincludes a handle assembly and an elongated portion extending distallyfrom the handle assembly. Each of the first end effectors and second endeffectors is configured to releasably engage a distal portion of theelongated portion of the surgical device.

The various embodiments disclosed herein may also be configured to workwith robotic surgical systems and what is commonly referred to as“Telesurgery.” Such systems employ various robotic elements to assistthe surgeon and allow remote operation (or partial remote operation) ofsurgical instrumentation. Various robotic arms, gears, cams, pulleys,electric and mechanical motors, etc. may be employed for this purposeand may be designed with a robotic surgical system to assist the surgeonduring the course of an operation or treatment. Such robotic systems mayinclude remotely steerable systems, automatically flexible surgicalsystems, remotely flexible surgical systems, remotely articulatingsurgical systems, wireless surgical systems, modular or selectivelyconfigurable remotely operated surgical systems, etc.

The robotic surgical systems may be employed with one or more consolesthat are next to the operating theater or located in a remote location.In this instance, one team of surgeons or nurses may prepare the patientfor surgery and configure the robotic surgical system with one or moreof the surgical instruments disclosed herein while another surgeon (orgroup of surgeons) remotely controls the instrument(s) via the roboticsurgical system. As can be appreciated, a highly skilled surgeon mayperform multiple operations in multiple locations without leavinghis/her remote console which can be both economically advantageous and abenefit to the patient or a series of patients.

The robotic arms of the surgical system are typically coupled to a pairof master handles by a controller. The handles can be moved by thesurgeon to produce a corresponding movement of the working ends of anytype of surgical instrument (e.g., end effectors, graspers, knifes,scissors, etc.) which may complement the use of one or more of theembodiments described herein. The movement of the master handles may bescaled so that the working ends have a corresponding movement that isdifferent, smaller or larger, than the movement performed by theoperating hands of the surgeon. The scale factor or gearing ratio may beadjustable so that the operator can control the resolution of theworking ends of the surgical instrument(s).

The master handles may include various sensors to provide feedback tothe surgeon relating to various tissue parameters or conditions, e.g.,tissue resistance due to manipulation, cutting or otherwise treating,pressure by the instrument onto the tissue, tissue temperature, tissueimpedance, etc. As can be appreciated, such sensors provide the surgeonwith enhanced tactile feedback simulating actual operating conditions.The master handles may also include a variety of different actuators fordelicate tissue manipulation or treatment further enhancing thesurgeon's ability to mimic actual operating conditions.

It will be understood that various modifications may be made to theembodiments disclosed herein. Therefore, the above description shouldnot be construed as limiting, but merely as exemplifications of variousembodiments. Those skilled in the art will envision other modificationswithin the scope and spirit of the claims appended thereto.

1. (canceled)
 2. An end effector for use with a surgical device, the endeffector comprising: a drive assembly; a needle assembly disposed inmechanical cooperation with the drive assembly, wherein rotation of thedrive assembly in a first direction causes a corresponding rotation ofthe needle assembly, the needle assembly including a pin; a helixassembly disposed in mechanical cooperation with the needle assembly,the helix assembly including a proximal end and a longitudinal slot; anda biasing element disposed in mechanical cooperation with the needleassembly and configured to bias the needle assembly distally withrespect to the drive assembly; wherein the needle assembly is movablewith respect to the helix assembly from a first position where the pinis out of alignment with the longitudinal slot of the helix assembly, toa second position where the pin is aligned with the longitudinal slot ofthe helix assembly, to a third position where the pin has been distallytranslated with respect to the helix assembly.
 3. The end effectoraccording to claim 2, wherein a predetermined amount of rotation of thedrive assembly with respect to the helix assembly causes a correspondingrotation of the needle assembly with respect to the helix assembly suchthat the needle assembly moves from its first position to its secondposition.
 4. The end effector according to claim 2, wherein when theneedle assembly is in the first position, engagement between the pin ofthe needle assembly and the proximal end of the helix assembly preventsthe needle assembly from moving distally with respect to the driveassembly.
 5. The end effector according to claim 4, wherein when theneedle assembly is in the second position, the biasing element causesthe pin to move distally within the longitudinal slot of the helixassembly such that the needle assembly is moved to the third position.6. The end effector according to claim 5, wherein rotation of the driveassembly when the needle assembly is in the third position causes thehelix assembly to rotate with respect to an outer tube.
 7. The endeffector according to claim 6, wherein rotation of the helix assemblywith respect to the outer tube causes proximal movement of the needleassembly with respect to the outer tube.
 8. The end effector accordingto claim 2, wherein the drive assembly includes a first arm and a secondarm, both of the first arm and the second arm are configured to directlycontact the needle assembly.
 9. The end effector according to claim 2,further comprising a suture disposed in mechanical cooperation with aneedle of the needle assembly.
 10. An end effector for use with asurgical device, the end effector comprising: a drive assembly defininga longitudinal axis; a needle assembly including at least one pin anddisposed in mechanical cooperation with the drive assembly; a helixassembly disposed in mechanical cooperation with the needle assembly,the helix assembly including at least one longitudinal slot and ahelical thread, the needle assembly is longitudinally translatablerelative to the helix assembly; and an outer tube disposed inmechanically cooperation with the helix assembly, the outer tubeincluding a helical groove configured to engage the helical thread ofthe helix assembly such that the helix assembly is rotatable about thelongitudinal axis relative to the outer tube.
 11. The end effectoraccording to claim 10, wherein the at least one pin of the needleassembly is configured to slide through the at least one longitudinalslot of the helix assembly.
 12. The end effector according to claim 10,wherein the at least one pin of the needle assembly is configured tomove from a first position where the at least one pin is free fromengagement with the at least one longitudinal slot of the helixassembly, to a second position where the at least one pin is within theat least one longitudinal slot of the helix assembly.
 13. The endeffector according to claim 10, wherein the at least one pin of theneedle assembly includes a first pin and a second pin.
 14. The endeffector according to claim 13, wherein the at least one longitudinalslot of the helix assembly includes a first longitudinal slot and asecond longitudinal slot, the first pin is configured to travel withinthe first longitudinal slot while the second pin travels within thesecond longitudinal slot.
 15. The end effector according to claim 10,wherein the drive assembly is fixed from longitudinal movement relativeto the outer tube.
 16. The end effector according to claim 10, furtherincluding a biasing element disposed in mechanical cooperation with theneedle assembly and configured to bias the needle assembly distallyrelative to the drive assembly.
 17. The end effector according to claim16, wherein rotation of the helix assembly relative to the outer tubecauses proximal movement of the needle assembly relative to the outertube.
 18. The end effector according to claim 10, wherein rotation ofthe helix assembly relative to the outer tube causes proximal movementof the needle assembly relative to the outer tube.
 19. The end effectoraccording to claim 10, wherein the needle assembly is rotatable aboutthe longitudinal axis relative to the helix assembly.
 20. The endeffector according to claim 19, wherein the needle assembly is rotatableabout the longitudinal axis relative to the outer tube.
 21. The endeffector according to claim 10, wherein the needle assembly is rotatableabout the longitudinal axis relative to the outer tube.